Dizziness - Vertigo
FDA Label NDC 55714-4508

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Dizziness - Vertigo (NDC 55714-4508). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage Section

Dizziness - Vertigo  Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.

Dosage & Administration Section

Directions:  ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

Active Ingredient Section

Absinthium 20x, Aconitum nap. 20x, Antimon. tart. 20x, Belladonna 20x, Bryonia 20x, Carbolicum acidum 20x, Colchicum 20x, Conium 20x, Ferrum metallicum 20x, Gelsemium 20x, Glonoinum 20x, Hyoscyamus 20x, Ipecac. 20x, Iris versicolor 20x, Lycopodium 20x, Nux vom. 20x, Petroleum 20x, Phosphorus 20x, Sepia 20x, Symphoricarpus racemosus 20x, Tabacum 20x, Theridion 20x, Zingiber 20x, Echinacea 8x, Hypericum 8x, Passiflora 8x, Valeriana 8x, Echinacea 3x, Hypericum 3x, Passiflora 3x, Valeriana 3x.

Purpose Section

Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.

Inactive Ingredient Section

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions? Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

Warnings Section

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children. 

Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Package Label

Package Label (R055 L01)

Package Label (R055 L01)

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